Coroflex ISAR 2000 Registry

NCT02629575 | Completed

• 1 other identifier: AAG-O-H-1408
• Study Type: observational
• Target: 2,877
• Locations: 3 countries
• Sites: 3

Brief Summary

Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries

Conditions

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• clinically driven Target Lesion Revascularization

  re-intervention of the target lesion

  9 months

Secondary Outcomes (6)

• Major Adverse Cardiac Events

  9 months

• Myocardial infarction rate

  9 months

• Cardiac death rate

  9 months

• Target lesion revascularization rate

  9 months

• Procedural success

  immediately after stent implantation (within the first 30 minutes)

Interventions

stenting with the Coroflex ISAR sirolimus-eluting stent DEVICE

coronary stenting

Also known as: Coroflex ISAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unselected patients with coronary de-novo and/or restenotic lesions

You may qualify if:

• patients suitable for percutaneous coronary intervention with proof of ischemia
• at least 18 years of age

You may not qualify if:

• Intolerance to sirolimus and/or probucol
• Allergy to components of the coating
• Pregnancy and lactation
• Complete occlusion of the treatment vessel
• Severely calcified stenosis
• Cardiogenic shock
• Risk of an intraluminal thrombus
• Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
• Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
• Severe allergy to contrast media
• Lesions which are untreatable with PTCA or other interventional techniques
• Patients with an ejection fraction of \< 30 %
• Vascular reference diameter \< 2.00 mm
• Treatment of the left stem (first section of the left coronary artery)
• Indication for a bypass surgery

Sponsors & Collaborators

• B. Braun Melsungen AG: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (3)

Charité University Hospital

Berlin, 13353, Germany

Location

Pusat Perubatan Universiti Malaya

Kuala Lumpur, 59100, Malaysia

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Related Publications (10)

• Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schomig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. doi: 10.1161/CIRCULATIONAHA.111.026732. Epub 2011 Jul 18.

  PMID: 21768546 BACKGROUND

• Nuruddin AAB, Ahmad WAW, Waliszewski M, Heang TM, Bang LH, Yusof AKM, Abidin IZ, Zuhdi AS, Krackhardt F. Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter? Cardiol Ther. 2021 Jun;10(1):175-187. doi: 10.1007/s40119-020-00204-4. Epub 2020 Dec 4.

  PMID: 33275200 DERIVED

• Krackhardt F, Waliszewski MW, Kherad B, Barth C, Marcelli D. Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients: A descriptive subgroup analysis in patients with renal impairment. Medicine (Baltimore). 2020 Jul 17;99(29):e21244. doi: 10.1097/MD.0000000000021244.

  PMID: 32702903 DERIVED

• Krackhardt F, Waliszewski M, Kocka V, Tousek P, Janek B, Hudec M, Lozano F, Roman KG, Del Blanco BG, Mauri J, Heang TM, Ahn TH, Jeong MH, Herberger D, Tomulic V, Levy G, Sebagh L, Rischner J, Pansieri M. Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease. Cardiovasc Drugs Ther. 2020 Jun;34(3):335-344. doi: 10.1007/s10557-020-06963-5.

  PMID: 32212061 DERIVED

• Krackhardt F, Kocka V, Waliszewski M, Tousek P, Janek B, Trencan M, Krajci P, Lozano F, Roman KG, Otaegui I, Del Blanco BG, Del Olmo VV, Nofrerias EF, Wachowiak L, Heang TM, Ahn TH, Jeong MH, Jung BC, Han KR, Piot C, Sebagh L, Rischner J, Pansieri M, Leschke M. Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice. Medicine (Baltimore). 2020 Feb;99(8):e19119. doi: 10.1097/MD.0000000000019119.

  PMID: 32080086 DERIVED

• Krackhardt F, Waliszewski M, Wan Ahmad WA, Kocka V, Tousek P, Janek B, Trencan M, Krajci P, Lozano F, Garcia-San Roman K, Otaegui Irurueta I, Garcia Del Blanco B, Wachowiak L, Vilalta Del Olmo V, Fernandez Nofrerias E, Ho Jeong M, Jung BC, Han KR, Piot C, Sebagh L, Rischner J, Pansieri M, Leschke M, Ahn TH. Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes. PLoS One. 2020 Jan 13;15(1):e0226606. doi: 10.1371/journal.pone.0226606. eCollection 2020.

  PMID: 31929543 DERIVED

• Krackhardt F, Waliszewski M, Rischner J, Piot C, Pansieri M, Ruiz-Poveda FL, Boxberger M, Noutsias M, Rios XF, Kherad B. Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6-month vs. 12-month dual-antiplatelet therapy (DAPT). Herz. 2019 Aug;44(5):433-439. doi: 10.1007/s00059-017-4675-x. Epub 2018 Jan 22.

  PMID: 29356832 DERIVED

• Kherad B, Waliszewski M, Leschke M, Kader MA, Bang LH, Ruiz-Poveda FL, Pieske B, Krackhardt F. 9-month results of polymer-free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all-comer population. J Interv Cardiol. 2018 Jun;31(3):338-344. doi: 10.1111/joic.12472. Epub 2017 Dec 4.

  PMID: 29205492 DERIVED

• Krackhardt F, Rosli MA, Leschke M, Schneider A, Sperling C, Heang TM, Pons M, Sousa PJ, Kherad B, Waliszewski M. Propensity score matched all comers population treated with ultra-thin strut bare metal and sirolimus-probucol coated drug-eluting stents of identical stent architecture. Catheter Cardiovasc Interv. 2018 Jun;91(7):1221-1228. doi: 10.1002/ccd.27306. Epub 2017 Sep 25.

  PMID: 28944613 DERIVED

• Krackhardt F, Kocka V, Waliszewski MW, Utech A, Lustermann M, Hudec M, Studencan M, Schwefer M, Yu J, Jeong MH, Ahn T, Wan Ahmad WA, Boxberger M, Schneider A, Leschke M. Polymer-free sirolimus-eluting stents in a large-scale all-comers population. Open Heart. 2017 Jun 6;4(2):e000592. doi: 10.1136/openhrt-2017-000592. eCollection 2017.

  PMID: 28761678 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Florian Krackhardt, Dr

  Charité Virchow Unversity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 14, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

ES (1); MY (1); DE (1)